This study is currently recruiting participants.
Number
000783-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children;Pregnant Women
Keywords
Immunotherapy; Rational Drug Combination; Immune Checkpoint; Epigenetic Drug Approach
Recruitment Keyword(s)
None
Condition(s)
Advanced Ovarian Cancer; Metastatic Cancer
Investigational Drug(s)
ZEN003694
Investigational Device(s)
Intervention(s)
Biological/Vaccine: Nivolumab Biological/Vaccine: Ipilimumab Drug: ZEN003694
Supporting Site
National Cancer Institute
Tumors that come back after treatment or spread throughout the body have a high risk of death. Epithelial ovarian cancer, in particular, is highly lethal: 63% of the women diagnosed with this disease in 2018 died. More effective treatments are needed.
Objective:
To test a study drug (ZEN003694) combined with two other drugs (nivolumab and ipilimumab) in people with advanced solid tumors or ovarian cancer.
Eligibility:
People aged 18 years and older who have a solid tumor or ovarian cancer. The cancer must have spread to other parts of the body and/or not responded to previous treatment.
Design:
Participants will be screened. They will have blood and urine tests. They will have a test of their heart function. Imaging scans will be taken. They will have a biopsy of their tumor.
Participants will take study drugs in 28-day cycles. They will take ZEN003694 as a capsule by mouth every day in the morning.
On the first day of each cycle, participants will get nivolumab; this drug is administered through a needle in a vein in the arm over 30 minutes. Some participants will also receive a third drug, ipilimumab, through a needle in a vein in the arm over 90 minutes. They will receive ipilimumab a maximum of 4 times.
Participants may continue with study treatment as long as the drugs are helping them.
Blood tests will be repeated throughout the study. Imaging scans will be repeated every 8 weeks.
Participants will have follow-up visits for up to a year after their last study treatment.
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ELIGIBILITY CRITERIA: -Patients must have histologically confirmed metastatic or recurrent solid tumor malignancy for which standard curative or palliative measures do not exist or are no longer effective --Dose escalation: Metastatic or recurrent solid tumors with measurable or evaluable disease --Dose expansion exploratory cohorts (nivolumab + ipilimumab + ZEN003694): Recurrent BRCAwt epithelial ovarian carcinoma patients who have progressed or recurred within <6 months from prior platinum-based therapy --Dose escalation and expansion exploratory cohorts: Patients must have measurable and biopsiable disease (at least two lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For patients in the dose escalation with evaluable disease, biopsy is mandated if feasible. -No more than 5 lines of prior therapy for the dose escalation and expansion phases -In the expansion cohorts, up to 2 prior lines in the platinum-resistant setting is allowed -Patients with primary refractory ovarian cancer (who progressed while on primary 1L platinum therapy) will be excluded in the dose expansion cohorts but allowed in the dose escalation cohort -Patients who have had chemotherapy or radiotherapy more than 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and who have recovered from adverse events due to agents administered more than 4 weeks earlier are eligible. -Age >=18 with ECOG <=1 -Women of child-bearing potential
-Patients must have histologically confirmed metastatic or recurrent solid tumor malignancy for which standard curative or palliative measures do not exist or are no longer effective
--Dose escalation: Metastatic or recurrent solid tumors with measurable or evaluable disease
--Dose expansion exploratory cohorts (nivolumab + ipilimumab + ZEN003694): Recurrent BRCAwt epithelial ovarian carcinoma patients who have progressed or recurred within <6 months from prior platinum-based therapy
--Dose escalation and expansion exploratory cohorts: Patients must have measurable and biopsiable disease (at least two lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For patients in the dose escalation with evaluable disease, biopsy is mandated if feasible.
-No more than 5 lines of prior therapy for the dose escalation and expansion phases
-In the expansion cohorts, up to 2 prior lines in the platinum-resistant setting is allowed
-Patients with primary refractory ovarian cancer (who progressed while on primary 1L platinum therapy) will be excluded in the dose expansion cohorts but allowed in the dose escalation cohort
-Patients who have had chemotherapy or radiotherapy more than 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and who have recovered from adverse events due to agents administered more than 4 weeks earlier are eligible.
-Age >=18 with ECOG <=1
-Women of child-bearing potential
Principal Investigator
Referral Contact
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